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The purpose of this research is to observe the daily loss of benefit from DBS therapy by performing a standardized set of tasks throughout the day while wearing an Apple Watch to collect movement and other physiological data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable device for tremor assessment | Experimental | Subjects already implanted with a deep brain stimulation (DBS) system for therapy for essential tremor wear an Apple Watch and complete tremor assessment tasks detailed through the BrainRISE app four times a day for two weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple Watch | Device | The smartwatch will collect data including accelerometry, heart rate, activity, move time, exercise time, stand time, steps, walking and running distance, heart rate variability, respiratory rate, six-minute walk, and flights climbed. During sleep, the smartwatch will collect daily nighttime physiologic data such as time in bed, average sleep time, sleep efficiency, wake after sleep onset, nocturnal heart rate, and nocturnal respiratory rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Acquire high-quality physiological signal characteristics from movement disorder patients. | Acquisition of high-quality physiological signals from 50 subjects with movement disorders over the course of two weeks and up to thirty subjects over one day with 90% compliance rate as determined by the number of study tasks completed by participants. | 12 Months |
| Acquire high-quality physiological tremor signals from movement disorder patients. | Measured by wrist accelerometry, which tracks the acceleration of the patients' wrists and is reported in m/sec^2 on a scale where 1.0 = 9.8m/s^2. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject feedback | Subject comfort, compliance, and convenience during the data collection as determined by a post-study assessment asking patients to rate their experience on a scale of 1-5 from hardest and most inconvenient to easiest and least inconvenient. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Klassen, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| BrainRISE app | Other | The app will play a prerecorded video, which will walk participants through tasks which include holding your arms in different postures, repeating different vowel sounds and phrases as prompted, and tracing different patterns on the phone screen. The tasks are video and audio recorded while being completed. Completing the tremor assessment tasks will take about 10 minutes. |
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